An interventional study of ABT Weight Loss Intervention in Weight Loss, Obesity and Overweight, sponsored by University of Florida. Completed at 1 site in United States. Open to female participants aged 14 Years to 19 Years. Per ClinicalTrials.gov, last updated 2023-10-05.
Sponsored by University of Florida · Not applicable, Interventional, and Treatment
The purpose of this pilot, feasibility study is to investigate the acceptability of an acceptance-based therapy healthy lifestyle intervention in adolescent girls with overweight/obesity.
Participants will attend 2 baseline clinic visits and adolescents will participate in an ABT healthy lifestyle intervention.
The intervention will include 15 sessions over 6 months.
A post-treatment visit will occur.
1,818 studies on the registry are indexed under Weight Loss; 286 are open to participants now.
This study's enrollment of 17 is below the median of 73 across 1,540 interventional studies indexed under Weight Loss.
Browse Weight Loss studies →University of Florida is the lead sponsor of 1,285 studies on the registry; 199 are open to participants now.
Of its 177 completed or terminated interventional studies of FDA-regulated products, 141 (80%) have results posted.
Counted across the registry records on this site, refreshed daily.
Go through the criteria one by one — yes, no or not sure — and take the list to your doctor or the study team. Kept in this browser only.
Exclusion Criteria:
Adolescent girls will attend healthy lifestyle sessions that include nutritional education and physical activity education and build skills in the areas of values clarification, mindfulness, self-regulation skills, acceptance of uncomfortable states, goal-setting, problem solving, and self-monitoring.
Behavioral: ABT Weight Loss Intervention
This includes 15 sessions that are each 90 minutes in length. Intervention sessions will be weekly for the first 2 months, bi-weekly for the next 2 months, and monthly for the last 2 months.
Number of Participants Recruited
Number of teens who enrolled and completed both initial baseline visits. The recruitment strategy will be deemed 'feasible' if 15 participants are recruited within the 8 weeks.
Time frame: Baseline; Week 8
Percentage of Participants Who Did Not Complete the Intervention.
The attrition strategy will be deemed "feasible" if there is less than 50% attrition at the end of the 6-month intervention. This percentage details attrition, or the percentage of participants who did not complete the intervention.
Time frame: Baseline; Month 6
Percentage of Participants Who Decide to Participate in the Intervention
Of the participants who completed baseline visits, this percentage details what percentage of enrollees decided to participate in the intervention. The study will be deemed "acceptable" if at least 80% of enrolled participants decide to participate in the intervention.
Time frame: Baseline; Week 1
Percentage of Participants Who Attend All Intervention Sessions.
This percentage details the percentage of those who attended all 15 intervention sessions among intervention completers (n=11). The study will be deemed 'acceptable' if at least 70% of intervention completers attend all sessions.
Time frame: Week 1; Week 24
Change in BMI Z-score
Body mass index (BMI) z-scores are measures of weight adjusted for the height, age, and sex of the child. BMI z-scores correspond with growth chart percentiles. These scores are calculated with an external reference rather than internal references. In this study, the Centers for Disease Control and Prevention SAS program was used to calculate scores based on 2000 CDC growth charts. Additionally, a clinically significant change in BMI z-score was defined as greater than or equal to -0.15 as this decrease has shown improvements in one or more cardiovascular disease risk factor. The central z-score value is 0, representing the population mean, and standard deviations below the mean indicate better outcomes.
Time frame: Baseline; Month 6
Participants were recruited in clinics or through social media.
| Milestone | ABT Intervention |
|---|---|
| Started | 13 |
| Completed | 11 |
| Not completed | 2 |
| Withdrew: Withdrawal by subject | 2 |
Number of teens who enrolled and completed both initial baseline visits. The recruitment strategy will be deemed 'feasible' if 15 participants are recruited within the 8 weeks.
| Participants | ABT Weight Loss Intervention |
|---|---|
| Number of Participants Recruited | 16 |
The attrition strategy will be deemed "feasible" if there is less than 50% attrition at the end of the 6-month intervention. This percentage details attrition, or the percentage of participants who did not complete the intervention.
| percentage of participants | ABT Weight Loss Intervention |
|---|---|
| Percentage of Participants Who Did Not Complete the Intervention. | 15.4 |
Of the participants who completed baseline visits, this percentage details what percentage of enrollees decided to participate in the intervention. The study will be deemed "acceptable" if at least 80% of enrolled participants decide to participate in the intervention.
| percentage of participants | ABT Weight Loss Intervention |
|---|---|
| Percentage of Participants Who Decide to Participate in the Intervention | 81.3 |
This percentage details the percentage of those who attended all 15 intervention sessions among intervention completers (n=11). The study will be deemed 'acceptable' if at least 70% of intervention completers attend all sessions.
| percentage of participants | ABT Weight Loss Intervention |
|---|---|
| Percentage of Participants Who Attend All Intervention Sessions. | 90.9 |
Body mass index (BMI) z-scores are measures of weight adjusted for the height, age, and sex of the child. BMI z-scores correspond with growth chart percentiles. These scores are calculated with an external reference rather than internal references. In this study, the Centers for Disease Control and Prevention SAS program was used to calculate scores based on 2000 CDC growth charts. Additionally, a clinically significant change in BMI z-score was defined as greater than or equal to -0.15 as this decrease has shown improvements in one or more cardiovascular disease risk factor. The central z-score value is 0, representing the population mean, and standard deviations below the mean indicate better outcomes.
| z-scores | ABT Weight Loss Intervention |
|---|---|
| Change in BMI Z-score | -0.15 ± 0.34 |
Collected over Adverse event data were collected over the course of baseline through study completion [6 months].. Non-serious events are listed at a 0% frequency threshold.
| Group | Deaths | Serious | Other |
|---|---|---|---|
| ABT Weight Loss Intervention | 0/13 (0%) | 0/13 (0%) | 0/13 (0%) |
| Age, Continuous(years) | ABT Intervention |
|---|---|
| Mean | 16.69 ± 1.65 |
| Sex: Female, Male(Participants) | ABT Intervention |
|---|---|
| Female | 13 |
| Male | 0 |
| Race/Ethnicity, Customized(Participants) | ABT Intervention |
|---|---|
| Hispanic/Latina | 2 |
| Not Hispanic/Latina | 11 |
| White | 7 |
| Black | 5 |
| Multiple Races | 1 |
| Highest parental education(Participants) | ABT Intervention |
|---|---|
| High school diploma/GED | 2 |
| Some college/associate degree | 3 |
| College graduate | 3 |
| Graduate or professional degree | 4 |
| Unknown | 1 |
| Body Mass Index (BMI)(kg/m^2) | ABT Intervention |
|---|---|
| Mean | 35.28 ± 5.50 |
Documents are hosted by the registry — open the source record to download them.
Plan to share: No
Ran from Aug 2018 to primary completion in Jul 2020, 23 months.
Results were first posted in Oct 2023, 3 years 2 months after primary completion.
Of 681 non-industry interventional studies with no phase under Weight Loss, half reached primary completion within 22 months of starting (the median), counting those still running; a quarter within 11 and three quarters within 43. This study's 23 months is close to that.
Counting every sponsor, half of 736 studies reached it within 22 months; a quarter within 9 and three quarters within 41.
How these figures are worked out, and which studies are left out of them.
This study is completed, as verified in Sep 2023. You cannot join it, but the record below documents what was studied.
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